NDC codes

FDA NDC Directory
Product NDC (as listed)50090-2097Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-2097Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50090-2097-0500902097001 KIT in 1 KIT (50090-2097-0)Marketed from Oct 12, 2015

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Ashlyna
Generic name (nonproprietary)
levonorgestrel and ethinyl estradiol and ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203163
Marketing start
Listing expires
Identifiers
Product ID 50090-2097_dfa0a295-8eca-42c0-a8c2-c2cec0eacfd2SPL ID dfa0a295-8eca-42c0-a8c2-c2cec0eacfd2SPL set ID 2004a53d-3f62-4c33-813a-94b1567fe465RxCUI 238019, 248310, 749761, 1603861

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N450090209700 followed by a unit qualifier and the quantity

Package 50090-2097-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

Ashlynais indicated for use by females of reproductive potential to prevent pregnancy. Ashlyna is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203163

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203163
ProductStrengthForm · routeLabelerProduct NDC
Ashlynalevonorgestrel and ethinyl estradiol and ethinyl estradiol—KitGlenmark Pharmaceuticals Inc., USA68462-646

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